INTRODUCTION TO QUALITY CONTROL AND HUGO™

HUGO™ (Hardy User Group Observer) provides a description of the quality control procedures used at Hardy Diagnostics. We certify that each lot of media you receive has been tested according to the protocol in this software program.

We provide the HUGO™ software as a service to our customers. It is intended to be of value in fulfilling licensing requirements and as a reference guide to supplement the user's quality control program. Many customers have found the manual to be valuable in providing suggestions when writing their laboratory's quality control procedures. All HUGO™ product documents are written in the CLSI format and may be used directly in our customer's manuals.

The information in HUGO™ is to be used in conjunction with the "QC Vouchers" that are sent with each shipment of media. The "QC Vouchers" contain certification of testing, lot numbers, storage instructions, and the expiration dates; thus eliminating the need for any additional paperwork, transcribing of numbers, or the peeling off of stickers by the technologist. Please see the keyword "QC Voucher" for more information.

Complete records for each specific batch and lot number are not routinely sent with each shipment, but are kept on file at Hardy Diagnostics and Certificates of Analysis are available online at www.HardyDiagnostics.com.

Distributed products, not manufactured by Hardy Diagnostics, are not routinely tested by Hardy Diagnostics unless there is an indication to do so. The performance testing of the manufacturer is accepted. These products are visually screened for obvious defects.

The testing procedures described in HUGO™ meet or exceed the requirements stated in the CLSI (Clinical and Laboratory Standards Institute - formerly NCCLS) publication Quality Control for Commercially Prepared Microbiological Culture Media (M22-A3). For more about CLSI recommendations, refer to the HUGO™ document "The CLSI (NCCLS) Standard and Recommendations for User QC of Media".

HUGO™ will be updated periodically to conform with any new CLSI regulations and to include additional products. Customers will be informed when an updated version of HUGO™ is available.

Hardy Diagnostics is an "in vitro medical device manufacturer" and follows federal "Good Manufacturing Practices". In addition, the manufacturing facility of Hardy Diagnsotics is certified to ISO 13485 standards. The CLSI guidelines are followed for the types of media that are listed in the publication M22-A3. Membership is maintained in the Association of Microbiological Diagnostics Manufacturers (AMDM) and the American Society for Microbiology (ASM).

Any comments, suggestions, or questions about the quality control program are always welcome. They may be directed to our technical service department by calling (800) 266-2222, extension 5658.

061609md